WHOLE-BLOOD TEST FOR TOTAL CHOLESTEROL BY A SELF-METERING, SELF-TIMING DISPOSABLE DEVICE WITH BUILT-IN QUALITY-CONTROL

A whole-blood test for total cholesterol has been developed that is pe rformed in a low-cost disposable flow device without user intervention (after sample addition). The device meters the sample, separates plas ma from erythrocytes, and precisely times plasma flow into various rea gent compartments, including a quality-assurance chamber. Test results are displayed as a well-defined and easily readable color bar. A qual ity-control window attests to the integrity of the test components. He re, we describe the assembly and individual functions of the device an d report its performance characteristics. Precision and accuracy studi es in four clinical studies at independent locations yielded total imp recision of <5% and an average bias of 1.35% vs the Abell-Kendall meth od.